Computers, systems and methods for screening databases to determine new adverse events and to develop proprietary new uses and proprietary kits containing warnings pertaining to the new adverse event information have been described in U.S. Pat. No. 6,219,674 and U.S. patent application Ser. No. 09/804,289. However, the systems and methods described in the '674 patent were less than ideal because not all adverse event information is commercially valuable. In order for adverse event information to be valuable it must be patentable (i.e. proprietary) by being novel, non obvious and having utility. Likewise, the systems and methods described in the '289 patent were less than ideal because, even if the adverse event data is patentable, it is not commercially valuable unless it is essential, that is, the information must be such that all manufacturers would need to include it with the sale of the corresponding product. Otherwise, manufacturers would continue to sell their products without the subject information. Conversely, if one were to simply patent all new uses for the product, drug, and the like, considerable time and money would be consumed, but there would by a low probability for commercial or financial return on the whole.
The government has carefully established codes and rules under which, for example in the medical field, manufacturers and/or distributors are required to notify or warn the public of known adverse events which could occur when certain products, including drugs, medicaments and the like, are ingested or used by human or veterinary patients. Regulations also apply to chemical products, including food supplements, which may be absorbed, ingested or inhaled. Similar notice or warnings must be attached to devices, particularly to medical devices. Moreover, if the warnings are not present, the product or device not only must be immediately removed from use by, and availability to, the public, but also significant fines and penalties can be levied against the manufacturer and/or distributor of the product or device for its failure to provide adequate notice and warning to the public. In addition, because such manufacture and/or distribution was permitted without the required notice or warning, the manufacture and/or distribution was practiced in violation of the law. As a result, those manufacturers and/or distributors risk criminal and/or civil liability to anyone adversely affected by the product or device during the time when it was on the market.
The government has failed to establish mechanisms by which products and devices are adequately screened for safety, i.e., for the possibility of essential adverse events which could affect the safety of the patient using the product or device. This is particularly true for medical products and devices. The screening that is conducted by manufacturers and/or distributors of such products and devices is typically small in scale and incomplete for all possible adverse events. Consequently, until the present invention, there has been a need in the art for reliable screening methods to eliminate or minimize the possibility of an essential adverse event that could affect a patient or consumer using a product or device, so that the consumer can trust that the product or device is “safe.”
In addition, the prior art has failed to contemplate business methods which involve detecting essential adverse events relating to a product or device, and then offering the refined proprietary data from such screens to the manufacturers and/or distributors of the product or device. Once the existence of such essential adverse data is known to the manufacturer and/or distributor, they are obligated to inform the public of the potential adverse event, or they must remove the product or device from the market. Because manufacturers are currently producing and distributing products and devices without restrictions on their use, they are available for use in screens to develop essential adverse event data, which when refined, would become proprietary. Thus, there also exists a substantial market for such refined, proprietary, essential adverse event data, and for the methods, systems and devices by which it is obtained, which would (1) meet the need in the art for steps which would enhance public safety with regard to the use of products and devices, and (2) offer to manufacturers and/or distributors of product and/or devices a way to (a) significantly improve public safety, (b) permit their products and devices to remain on the market, and (c) reduce their risk of liability for the occurrence of an adverse event with the use of their products or devices.